Completed

NCT Number: NCT04698668

Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy

Virtual reality obtained by the fusion of images can be applied to several fields of medicine leading to the so called "augmented reality". Since 2017 investigators have been using a new digital angiographic system (Discovery IGS 40, General Electrics), where fluoroscopy can be fused with pre-procedural CT o MRI. Specifically the present study aimed at verifying the advantages that fusion imaging could bring in EUS-guided drainage of post-pancreatitis fluid collection (PFC), i.e. pseudocysts or WON, in terms of more appropriate visualization, drainage approach and time needed for resolution.

Completed

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Key information

Conditions

Pseudocyst Walled Off Cavity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS-AUSL Reggio Emilia

Reggio Emilia, RE, Italy

About this study

17 drainages performed with traditional radiology (group 1) were retrospectively compared with 14 ones achieved with the fusion approach (group 2). The two population were homogenous for age, sex, pancreatitis etiology and indication for drainage whereas PFCs of group 2 were larger (663 cm3 vs 437 cm3), more frequently WON than pseudocysts and were treated more precociously. As for procedure, in the group 2, thanks to fusion imaging, endoscopists didn't need ever contrast media - that was pivotal with traditional radiology - to adequately define lesion morphology. LAMS (Axios) stents were placed mainly in group 2, while in group 1 other types of stent were used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with post-pancreatitis PCF endoscopically drained

Exclusion criteria

refuse to sign the informed consent

Treatment and study plan

fusion imaging

Device

To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field

Primary outcomes

clinical and radiological resolution of the PFC

Time frame: 12 months

complete emtying of the PFC tighter with resolution of patients' symptomps
time of radiological resolution

Time frame: 12 months

time taken for the complete emtying of the PFC

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jan 7, 2021
Registry last updated: Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.